ConsultaTM CRT-D Clinical Evaluation Study - Full Text View

Sponsored by:	Medtronic Bakken Research Center
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00526162

Purpose

The purpose of the Consulta clinical study is to evaluate the overall system safety and clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D).

Condition	Intervention
Tachyarrhythmias Heart Failure Ventricular Dysfunction	Device: Bi-ventricular Implantable Cardioverter Defibrillator

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Heart Failure Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Clinical Study to Evaluate System Safety and Clinical Performance of the ConsultaTM CRT-D Device

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:

Confirm safety of the device by assessing the percentage of subjects with an unanticipated device effects at 1-month post implant. [ Time Frame: 1 month ]

Secondary Outcome Measures:

Summarize all harmful events (study related and non-study related) during the study and evaluate system performance [ Time Frame: 1 month ]

Estimated Enrollment:	80
Study Start Date:	October 2007
Estimated Study Completion Date:	May 2008

Arms	Assigned Interventions
1: Experimental	Device: Bi-ventricular Implantable Cardioverter Defibrillator Implantation of a Bi-ventricular Implantable Cardioverter Defibrillator

Detailed Description:

The Consulta CRT-D is an investigational bi-ventricular device that provides atrial and ventricular tachyarrhythmia detection and therapy, cardioversion, defibrillation and cardiac resynchronization therapy.

The study will be a prospective, non-randomized, multicenter clinical study, conducted in approximately 18 centers.

To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the Consulta device. Data will be collected at baseline (enrollment), implant, 1-, 3-, and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), unscheduled follow-up visits, System Modifications, Technical Observations, Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of death.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who have an indication for a defibrillator.
Patients who are optimally treated with medication.
Patients who are NYHA Class III or IV

Exclusion Criteria:

Patients with a life expectancy less than the duration of the study.
Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients.
Patients with mechanical tricuspid heart valves.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526162

Contacts

Contact: Consulta Clinical Study Team

consulta.brc@medtronic.com

Locations

Germany
Hospital	Recruiting
City, Germany
Principal Investigator: Doctor Doctor

Sponsors and Collaborators

Medtronic Bakken Research Center

Investigators

Study Chair:	Consulta Clinical Study Team	Medtronic Bakken Research Center
Study Chair:	Consulta Clinical Study Team	Medtronic Bakken Research Center

More Information

Study ID Numbers:	112
Study First Received:	September 6, 2007
Last Updated:	October 30, 2007
ClinicalTrials.gov Identifier:	NCT00526162
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Denmark: Danish Medicines Agency; Norway: Directorate for Health and Social Affairs; Sweden: Medical Products Agency; Netherlands: Dutch Health Care Inspectorate; Germany: Federal Institute for Drugs and Medical Devices; Austria: Federal Ministry for Health and Women; Switzerland: Swissmedic; Israel: Ministry of Health

Study placed in the following topic categories:

Ventricular Dysfunction
Heart Failure
Heart Diseases
Tachycardia
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009